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The animals were randomly housed under a 12-hour light/dark cycle, with five mice per cage or individually, depending on the experimental requirements

All subjects provided written informed consent prior to trial-related activities and both trials were conducted in accordance with the Declaration of Helsinki [36], International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice [37] and FDA 21 Code of Federal Regulations 312.120 [38] guidelines